Aksigen

  1. ADVERSE EVENT REPORTING

    Aksigen Hospital Care is committed to ensure the safety of all patients who receive our products. Every medicine has potential benefits and risks. Whenever any medicine is used, the possible risks are weighed against the expected benefits. The full safety profile of any medicine is established only after years of research and clinical use. Continuous monitoring of the risks associated with any medicine is necessary to ensure that the benefits outweigh possible risks.

    For this purpose, ‘Report any suspected adverse event to Aksigen Hospital Care medication’ as described below.  

    What is an adverse event?

    An adverse event is any undesirable experience associated with the use of a medicinal product in a patient. It is commonly referred to as ‘side effect’.

    It includes:

    • • Undesirable symptoms and signs e.g. headache, vomiting, abnormal ECG
    • • Medication errors e.g. wrong dose, intravenous administration instead of intramuscular
    • • Overdose
    • • Misuse and Abuse
    • • Use in pregnancy and breastfeeding
    • • Product technical complaints e.g. discolored or deteriorated products, improper labeling

    Why report adverse events?

    It ensures that we don’t miss out on important data which could help us use our medicines more effectively and safely.
    It helps in identifying rare adverse effects, unexpected/unknown adverse effects, drug/food interactions with medications, unknown risk factors and long-term safety profile of the medications

    What to report? (Necessary minimum information)

    1. Patient particulars
    This identifies the person who experienced the Adverse Event. The particulars include initials, age, sex etc.
    2. Event particulars
    These describe the symptom/sign. Additional data include: onset, course and outcome of the event.
    3. Reporter details
    You should provide your name, address and phone number as you may need to be contacted for further information.
    If you are not a healthcare professional, provide details of the prescribing doctor too.
    4. Drug details
    These include name, batch number, dosage etc. of the medicinal product suspected to cause the adverse event

    How to report?

    You can report the Adverse Event by downloading the Adverse Event Report Form and sending it to pharmacovigilance unit of Aksigen Hospital Care through one of the modes provided further below.

    You may contact the pharmacovigilance unit of Aksigen Hospital Care at

    Fax: +91- 22-45043355
    Phone: +91- 22-45043347
    E-mail: pv@aksigen.com

    Address:
    Clinical Research & Pharmacovigilance,
    Bharat Serums and Vaccines Ltd.,
    3rd Floor, Liberty Tower, Plot No. K-10,
    Behind Reliable Plaza,
    Kalwa Industrial Estate, Airoli, Navi Mumbai,
    India – 400708.